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Randomized phase III study of 5-FU continuous infusion (5-FUci) versus CPT-11 plus CDDP (CP) versus S-1 alone (S-1) in advanced gastric cancer (JCOG9912)

Randomized phase III study of 5-FU continuous infusion (5-FUci) versus CPT-11 plus CDDP (CP) versus S-1 alone (S-1) in advanced gastric cancer (JCOG9912) - Randomized phase III study of 5-FU continuous infusion (5-FUci) versus CPT-11 plus CDDP (CP) versus S-1 alone (S-1) in advanced gastric cancer (JCOG9912)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-C000000062
Enrollment
690
Registered
2005-08-16
Start date
2000-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced or recurrent gastric cancer

Interventions

continuous infusion of 5-fluorouracil combination of irinotecan and cisplatin oral administration of S-1

Sponsors

Japan Clinical Oncology Group(JCOG)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) unresectable or recurrent histologically proved gastric cancer 2) adequate oral intake 3) age 20 or older and 75 or younger 4) Performance Status (ECOG):0, 1, 2 5) measurable or unmeasurable lesions 6) preserved organ functions 7) no esvere medical condition 8) no prior chemotherapy for gastric cancer 9) written informed consent

Exclusion criteria

Exclusion criteria: 1) patient with marked infection or inflammation 2) patient with severe peritoneal metastasis 3) patient with massive plueral effusion 4) patient with metastasis to CNS 5) patiet with diarrhea 4 or more times per day 6) patient severe medical condition 7) patient with other concurrent malignancy affecting on survival or adverse events 8) pregnant or nursing patient or with intent to bear baby 9) patient evaluated to be inadequate by a attending doctor 10) patient reqiring nutritional support

Design outcomes

Primary

MeasureTime frame
overall survival

Secondary

MeasureTime frame
time to treatment failure, incidences of adverse events, response rate, non-hospitalized survival

Countries

Japan

Contacts

Public ContactNarikazu Boku, MD

JCOG9912 Coordinating Office Div. of Gastrointestinal Oncology, Shizuoka Cancer Center

JCOG_sir@ml.jcog.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026